What exactly is happening with AstraZeneca?

McGiver · 25-02-2021 03:16PM

Bambi wrote:

Completely ignoring the abyssmal failure of the EU throught the vaccine rollout and AZ having done nothing that was in breach of their contract with the EU

Blah blah blah. UK good, EU bad. Go to Ulster or England with this pal.

Bambi wrote:

The Brits got their vaccine strategy right, we left ours to the EU and they made a pigs mickey of it.

THE UK IS A SINGLE COUNTRY.
The EU is a CONFEDERATION OF 27 COUNTRIES. Breathe and repeat.

That is 27 times more complexity as a minimum.
Is the roll-out 27 times slower here? No.

UK is 66m people. The EU is 450m people. That's 7 times more.
Is the roll-out here 7 times slower here? No.

The EU has the best roll-out after Israel, UAE, US, UK and Chile. One of the best in the world, in fact.

Bambi wrote:

Our ties to the EU have done us zero favours throughout the Lockdown, we have a government that sees itself as the branch manager for the head office in Brussels rather than capable of making its own decisions.

Delusional nonsense. Did you read that in the Daily Express?

is_that_so · 25-02-2021 03:22PM

robinph wrote: »

The UK wasn't taking massive risks with the vaccine program.

Throwing money at it early wasn't a gamble, they were throwing money at everything at that stage and if the vaccine was a total dud then it would just be added to the list of failures. But that was a big list so one more makes no difference.
It wasn't a big risk to approve it early. The trial data was in and is the same data that other bodies used to approve it.
It wasn't even a big risk to approve it for over 60s despite the lack of significant trial data. There was also a lack of anything to suggest that it would be dangerous to give to over 60s. Worst case was that it did nothing, but compared to lots of people dying from covid against most people not dying of covid may as well stick a potentially useless vaccine in people's arms and see.
Likewise with the longer gap between the doses, far better to have lots of people partially protected than a small number of people highly protected (and still way above the effectiveness that was being anticipated from any vaccinations this time last year).

It's certainly not how the process would work normally, but it's not normal times. Try anything as long as it's not worse than what's happening so far.

Not following the manufacturer's advice makes them an outlier and it was a risk that no other country would take. They got lucky, a positive outcome, but it was unquestionably taken because of the utter shambles of the rest of the COVID crisis.

astrofool · 25-02-2021 03:37PM

MrMusician18 wrote: »

That's not accurate. Approval and purchasing are completely separate processes.

Most people are complaining that the EMA is too slow at approval (again explained by the pharma companies choosing to go with the higher data standard required for conditional vs. emergency approval), it is unlikely that we would have gone our own way on purchasing, but stayed with EMA for approval (e.g. we wouldn't be able to buy Sinovac/Pharm or Sputnik), it would be a worst of both worlds approach, but you're correct, a country could go down that route if they really wanted to.

Cazale · 25-02-2021 03:40PM

Sister in law works for the HSE and got the first AZ dose the other day. Next dose is in 12 weeks time. Is this the standard now?

Raisins · 25-02-2021 03:43PM

robinph wrote: »

The UK wasn't taking massive risks with the vaccine program.

Throwing money at it early wasn't a gamble, they were throwing money at everything at that stage and if the vaccine was a total dud then it would just be added to the list of failures. But that was a big list so one more makes no difference.
It wasn't a big risk to approve it early. The trial data was in and is the same data that other bodies used to approve it.
It wasn't even a big risk to approve it for over 60s despite the lack of significant trial data. There was also a lack of anything to suggest that it would be dangerous to give to over 60s. Worst case was that it did nothing, but compared to lots of people dying from covid against most people not dying of covid may as well stick a potentially useless vaccine in people's arms and see.
Likewise with the longer gap between the doses, far better to have lots of people partially protected than a small number of people highly protected (and still way above the effectiveness that was being anticipated from any vaccinations this time last year).

It's certainly not how the process would work normally, but it's not normal times. Try anything as long as it's not worse than what's happening so far.

What kind of nonsense is this. That’s not the way science works and for a a very good reason.

A.You don’t approve vaccines because there’s nothing to say they’re unsafe. They’re approved if they’re proven to be effective and safe. The EU was being given new data by AZ all across Xmas long after the UK had approved it for emergency use. The EU didn’t approve it on the same data.

B. Spreading the time between doses against manufacturers advice was and is a risk. We’ll see whether it causes resistant strains in people partially protected against covid who get covid. The more people who get covid while partially protected the higher the risk. Deciding to partially protect people because it’s better than no protection is fools logic. Sounds appealing intuitively if you don’t know what you’re talking about.

C. The EU equally threw money at absolutely every potential vaccine that came to the market. EU money is which was invested in AZ at an early stage is partially responsible for its success.

D. The emergency approval the UK gave the vaccine not the same as the approval the EU gave. For example, the EU refused to let the pharma companies off the hook of the vaccines caused side effects or were dangerous or defective etc. The UK were happy to absorb that risk.

25-02-2021 03:44PM

is_that_so wrote: »

Not following the manufacturer's advice makes them an outlier and it was a risk that no other country would take. They got lucky, a positive outcome, but it was unquestionably taken because of the utter shambles of the rest of the COVID crisis.

Manufacturers advice?

Yiu make it sound like they washed a woolly jumper on a cotton wash.

robinph · 25-02-2021 03:48PM

is_that_so wrote: »

Not following the manufacturer's advice makes them an outlier and it was a risk that no other country would take. They got lucky, a positive outcome, but it was unquestionably taken because of the utter shambles of the rest of the COVID crisis.

Agreed, its an outlier. But where was the risk?

Nothing to suggest anything negative would happen, just that it might not be quite so positive a result as if following the guidelines. If you have a population of 20 people and only 10 vaccines, are you better with 5 people vaccinated to 80‰ effective or 10 people vaccinated to 70% effectiveness and worry about dose 2 in a couple of months?

Sitting around waiting for enough doses to do everything perfectly can be thrown out the window when you're dealing with an emergency. The UK undoubtedly screwed up in lots of things, but the vaccine program was a sensible adjustment of normal procedures.

Call me Al · 25-02-2021 03:49PM

Cazale wrote: »

Sister in law works for the HSE and got the first AZ dose the other day. Next dose is in 12 weeks time. Is this the standard now?

I'm unsure what you mean by standard?
Yes, AstraZeneca has a 12 week gap between doses. That is as designed and recommended as far as I know.

25-02-2021 03:57PM

Raisins wrote: »

B. Spreading the time between doses against manufacturers advice was and is a risk. We’ll see whether it causes resistant strains in people partially protected against covid who get covid. The more people who get covid while partially protected the higher the risk. Deciding to partially protect people because it’s better than no protection is fools logic. Sounds appealing intuitively if you don’t know what you’re talking about.

can you explain how you differentiate between partially protected and fully protected?

Call me Al · 25-02-2021 04:03PM

Aegir wrote: »

Manufacturers advice?

Yiu make it sound like they washed a woolly jumper on a cotton wash.

Is this another one of your "jokes"?
The poster is telling it like it is.
I think its patently obvious to everyone that they are vaccinating people outside of the manufacturer's guidelines.
https://blogs.bmj.com/bmj/2021/01/20/revisiting-the-uks-strategy-for-delaying-the-second-dose-of-the-pfizer-covid-19-vaccine/

is_that_so · 25-02-2021 04:05PM

robinph wrote: »

Agreed, its an outlier. But where was the risk?

Nothing to suggest anything negative would happen, just that it might not be quite so positive a result as if following the guidelines. If you have a population of 20 people and only 10 vaccines, are you better with 5 people vaccinated to 80‰ effective or 10 people vaccinated to 70% effectiveness and worry about dose 2 in a couple of months?

Sitting around waiting for enough doses to do everything perfectly can be thrown out the window when you're dealing with an emergency. The UK undoubtedly screwed up in lots of things, but the vaccine program was a sensible adjustment of normal procedures.

I'd favour following instructions on the label and on balance the EU approach to wait for the EMA. There is the risk of people catch COVID between delayed shots and it doesn't help with vaccine hesitancy, a factor already in some countries. None of that has happened to date in the UK apart from stupid British vaccine idiots. If there are no major issues in the gap they've opted for then it's fine but it's not going to be the first strategy any country will opt for future pandemics.

25-02-2021 04:10PM

Call me Al wrote: »

Is this another one of your "jokes"?
The poster is telling it like it is.
I think its patently obvious to everyone that they are vaccinating people outside of the manufacturer's guidelines.
https://blogs.bmj.com/bmj/2021/01/20/revisiting-the-uks-strategy-for-delaying-the-second-dose-of-the-pfizer-covid-19-vaccine/

because that is the only data the manufacturers have and can't give any other advice.

It wasn't a rash decision made so they can look good, this was a decision taken by the four chief medical officers of the UK after consideration by the joint Committee on Vaccination and Immunisation based on their (somewhat considerable) knowledge and experience and their own review of the data from the trials.

DaSilva · 25-02-2021 04:26PM

A lot of the talk here about dosing intervals paints a very different picture from what I've read and heard about from experts.

There are many multi dose vaccines in use in the world and the intervals are usually months to years not weeks. So these covid vaccines are the exception not the rule. Why? What I understand is that multiple doses improve immune response, but there has to be a gap for it to have that boosting effect, and the minimum gap seems to be about 3 weeks, but from a immune response point of view it is not the ideal gap, just the shortest where you still get a benefit.

It's a complicated trade off of level of immediate immunity versus eventual level of immunity with added complexity of population level of immunity and vaccine supply. It's not just people deciding to roll a dice for political points and others following the manufactures docket to the letter.

astrofool · 25-02-2021 04:29PM

Aegir wrote: »

because that is the only data the manufacturers have and can't give any other advice.

It wasn't a rash decision made so they can look good, this was a decision taken by the four chief medical officers of the UK after consideration by the joint Committee on Vaccination and Immunisation based on their (somewhat considerable) knowledge and experience and their own review of the data from the trials.

It was a decision taken due to their high (and still high) death count stemming from failure to stop the spread of the disease multiple times.

It was not a decision made due to a position of power, it was made due to being in a weak position in tacking the spread of SARS-COV2 and hospitals being overwhelmed with COVID-19 patients.

The pharma companies developed and tested the vaccines as fast as they safely could, including the dosing regimen, which has been pointed out multiple times on multiple threads in answer to those saying that vaccines take 10 years to develop "safely". The UK then took all that effort, and ignored it due to panic, and followed the advice of doctors and experts who did not develop or test the vaccines.

25-02-2021 04:34PM

astrofool wrote: »

It was a decision taken due to their high (and still high) death count stemming from failure to stop the spread of the disease multiple times.

It was not a decision made due to a position of power, it was made due to being in a weak position in tacking the spread of SARS-COV2 and hospitals being overwhelmed with COVID-19 patients.

The pharma companies developed and tested the vaccines as fast as they safely could, including the dosing regimen, which has been pointed out multiple times on multiple threads in answer to those saying that vaccines take 10 years to develop "safely". The UK then took all that effort, and ignored it due to panic, and followed the advice of doctors and experts who did not develop or test the vaccines.

So let me get this right.

You think the head of the Oxford vaccine group doesn’t know what he is doing?

Raisins · 25-02-2021 04:35PM

Aegir wrote: »

can you explain how you differentiate between partially protected and fully protected?

Im talking about people who have one dose of a two dose vaccine.

astrofool · 25-02-2021 04:36PM

DaSilva wrote: »

A lot of the talk here about dosing intervals paints a very different picture from what I've read and heard about from experts.

There are many multi dose vaccines in use in the world and the intervals are usually months to years not weeks. So these covid vaccines are the exception not the rule. Why? What I understand is that multiple doses improve immune response, but there has to be a gap for it to have that boosting effect, and the minimum gap seems to be about 3 weeks, but from a immune response point of view it is not the ideal gap, just the shortest where you still get a benefit.

It's a complicated trade off of level of immediate immunity versus eventual level of immunity with added complexity of population level of immunity and vaccine supply. It's not just people deciding to roll a dice for political points and others following the manufactures docket to the letter.

With other vaccines there are trials done to verify all the different dosing schedules, as has been found with AZ, the efficacy and protection against serious COVID can vary by dosage and by dosing schedule. Even more preposterous was doing this with the mRNA vaccines which are employing new techniques for stimulating immune response. We simply don't know what we don't know and we can guess a bit based on other vaccines and lab trials, but until it's been field tested, we could (for example) see the immune response drop off rapidly after 3-4 weeks, leaving an injected "immune" patient vulnerable again. It's not as if the pharma companies want a 2 dose schedule, but their experts deemed it necessary to provide protection, then the UK experts who don't manufacture mRNA vaccines decided to override them.

astrofool · 25-02-2021 04:38PM

Aegir wrote: »

So let me get this right.

You think the head of the Oxford vaccine group doesn’t know what he is doing?

Present your data, why is the head of the Oxford vaccine group overriding dosage schedule for a vaccine he didn't create? (if that's what you're implying).

Is this meant to be a "Gotcha!" moment or something?

fly_agaric · 25-02-2021 04:38PM

Bambi wrote: »

Brits got lucky
Israelis got lucky
Yanks got lucky
Denmark got lucky

US - kind of in a class of their own aren't they? We all know "America is First" too and Trump was very open about that too.

UK - also adoped a bit of a Devil take the Hindmost policy in terms of looking out for themselves (hence AZ controversy). Not quite as open about it as the US because, well, they are not a superpower and they still rely on others to an extent.

The bad part of me would love to be a fly on the wall (but at a very safe distance...!) some day if the populist/nationalist types running the UK ever happen to have the ill luck to run up against exact equivalents in Fr/Ger/Italy etc in the future! Unlike the EU itself, or current politicians of the main EU countries, their ilk will fight fire with fire all day long + enjoy it, but alot of people will be badly burned in the end.

Israel - reportedly giving data to Pfizer in (part) exchange for priority access to vaccines. Given how we have no citizen unique id or id card in this country & how (imo) irrationally suspicious our population is about even government departments knowing "too much" about them, how would such a deal have gone down here?

Maybe people would be okay with the quid-pro-quo though given "lockdown" desperation is really setting in now?

https://www.npr.org/2021/01/31/960819083/vaccines-for-data-israels-pfizer-deal-drives-quick-rollout-and-privacy-worries

edit: Of course, we are also operating inside the EU where data protection is quite strict compared to the rest of the world.
Govt. may be allowed to collect it, but sharing of such sensitive data with a private company (??).

Denmark - not sure of point about them as they are in the EU too, and not "up there" with the US/UK in terms of having sufficient vaccine supplies delivered and already rolling it out to very large % of the population.

brickster69 · 25-02-2021 04:39PM

Pharma CEO's explaining things at the EU

https://www.pscp.tv/w/1yoJMABRNOeJQ

Cazale · 25-02-2021 04:40PM

Call me Al wrote:

I'm unsure what you mean by standard? Yes, AstraZeneca has a 12 week gap between doses. That is as designed and recommended as far as I know.

Standard as in is this agreed interval between the two shots. I got the two Pfizer jabs with a three week interval. Thought the AZ was the same which from your information it is not.

AngeloArgue · 25-02-2021 04:49PM

https://www.irishtimes.com/news/ireland/irish-news/health-staff-will-not-be-offered-choice-of-covid-19-vaccine-hse-1.4494973?mode=sample&auth-failed=1&pw-origin=https%3A%2F%2Fwww.irishtimes.com%2Fnews%2Fhealth%2Fcoronavirus%2Fhealth-staff-will-not-be-offered-choice-of-covid-19-vaccine-hse-1.4494973

Looks like the same vaccine hesitancy seen on the continent is starting to spread to Irish HCWs. HSE saying they will neither withdraw the product or offer a choice.

Call me Al · 25-02-2021 04:51PM

DaSilva wrote: »

A lot of the talk here about dosing intervals paints a very different picture from what I've read and heard about from experts.

There are many multi dose vaccines in use in the world and the intervals are usually months to years not weeks. So these covid vaccines are the exception not the rule. Why? What I understand is that multiple doses improve immune response, but there has to be a gap for it to have that boosting effect, and the minimum gap seems to be about 3 weeks, but from a immune response point of view it is not the ideal gap, just the shortest where you still get a benefit.

It's a complicated trade off of level of immediate immunity versus eventual level of immunity with added complexity of population level of immunity and vaccine supply. It's not just people deciding to roll a dice for political points and others following the manufactures docket to the letter.

And as such you expect it to be trialled and measured correctly by the manufacturer.

In many ways I suppose we should be thankful that the UK are willing to allow their population be this massive trial in real time.

is_that_so · 25-02-2021 04:53PM

AngeloArgue wrote: »

https://www.irishtimes.com/news/ireland/irish-news/health-staff-will-not-be-offered-choice-of-covid-19-vaccine-hse-1.4494973?mode=sample&auth-failed=1&pw-origin=https%3A%2F%2Fwww.irishtimes.com%2Fnews%2Fhealth%2Fcoronavirus%2Fhealth-staff-will-not-be-offered-choice-of-covid-19-vaccine-hse-1.4494973

Looks like the same vaccine hesitancy seen on the continent is starting to spread to Irish HCWs. HSE saying they will neither withdraw the product or offer a choice.

That's just HCWs being precious, yeah it could discourage others and it's a pretty awful message.

25-02-2021 04:54PM

astrofool wrote: »

Present your data, why is the head of the Oxford vaccine group overriding dosage schedule for a vaccine he didn't create? (if that's what you're implying).

Is this meant to be a "Gotcha!" moment or something?

it isn't a gotcha moment at all, I am just wondering on what basis you believe that the JCVI, which includes pretty extraordinary levels of knowledge on vaccinations and and medicines in general, is doing the wrong thing.

DaSilva · 25-02-2021 04:57PM

astrofool wrote: »

With other vaccines there are trials done to verify all the different dosing schedules, as has been found with AZ, the efficacy and protection against serious COVID can vary by dosage and by dosing schedule. Even more preposterous was doing this with the mRNA vaccines which are employing new techniques for stimulating immune response. We simply don't know what we don't know and we can guess a bit based on other vaccines and lab trials, but until it's been field tested, we could (for example) see the immune response drop off rapidly after 3-4 weeks, leaving an injected "immune" patient vulnerable again. It's not as if the pharma companies want a 2 dose schedule, but their experts deemed it necessary to provide protection, then the UK experts who don't manufacture mRNA vaccines decided to override them.

This is a totally unfair characterisation, there is plenty of basic science and understanding of vaccines and immunity to make decisions like this in an emergency situation, it is definitely not preposterous. The mRNA vaccines were even tested with different dosage and schedules in the earlier phases. All previous knowledge about vaccines and immunity is not suddenly erased when a new virus emerges. On top of that we have some of the most well replicated vaccine science ever here, we have multiple different countries/companies/trials/vaccine design/dosing quantities/dosing schedules demonstrating efficacy against this virus. I actually wonder is this maybe one of the best understood viruses in the world. It's entirely reasonable to diverge from the path of maximum caution in an emergency when there is a lot of existing science and knowledge to help us make more effective but potentially riskier decisions.

deeperlearning · 25-02-2021 04:58PM

AngeloArgue wrote: »

https://www.irishtimes.com/news/ireland/irish-news/health-staff-will-not-be-offered-choice-of-covid-19-vaccine-hse-1.4494973?mode=sample&auth-failed=1&pw-origin=https%3A%2F%2Fwww.irishtimes.com%2Fnews%2Fhealth%2Fcoronavirus%2Fhealth-staff-will-not-be-offered-choice-of-covid-19-vaccine-hse-1.4494973

Looks like the same vaccine hesitancy seen on the continent is starting to spread to Irish HCWs. HSE saying they will neither withdraw the product or offer a choice.

This is NOT vaccine hesitancy. In fact, it is the opposite.

It is a union advocating for a BETTER vaccine for its members.

Icantthinkof1 · 25-02-2021 05:01PM

Cazale wrote: »

Sister in law works for the HSE and got the first AZ dose the other day. Next dose is in 12 weeks time. Is this the standard now?

I was told 10weeks when I got mine

is_that_so · 25-02-2021 05:03PM

deeperlearning wrote: »

This is NOT vaccine hesitancy. In fact, it is the opposite.

It is a union advocating for a BETTER vaccine for its members.

L'Oreal members! They all WORK.

DaSilva · 25-02-2021 05:03PM

Call me Al wrote: »

And as such you expect it to be trialled and measured correctly by the manufacturer.

In many ways I suppose we should be thankful that the UK are willing to allow their population be this massive trial in real time.

Let me ask you a simple question. Given all the knowledge we have about vaccines and immunity from all the different vaccines, dosing regimes and dosing schedules, would you say, we have 0 evidence that the Pfizer vaccine given at 12 weeks will work effectively?

What exactly is happening with AstraZeneca?

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